Medical device companies often face a costly and time-consuming regulatory maze that drags out product launches by years and adds hundreds of thousands in expenses. FormlyAI aims to fix that with an AI-powered certification platform that speeds approval timelines by up to 10x while reducing regulatory costs by an average of $70,000 per client.
The startup just raised $2 million in seed funding led by Heal Capital, with participation from Gradient, Massive Tech Ventures, Gaingels, and Mana Ventures, to accelerate expansion across the US and Europe and scale its team to meet growing demand.
In an exclusive conversation with TFN, Dr. Spencer Todd, co-founder and CEO of FormlyAI, and a former FDA regulatory expert, said, “We are medical device startup founders and regulatory experts ourselves with the mission to make the burden of medical device compliance easy for everyone. This gets more life-changing technology to the market faster and drives health innovation forward to save lives.”
Combining AI-embedded software with expert consulting
FormlyAI was founded in 2023 by Todd and Severin Hoegl, a medtech entrepreneur whose last company reached 10,000 patients and raised €5 million before acquisition. The startup’s secret weapon is combining AI-embedded software that acts like a digital quality management system with expert consulting.
As Todd put it, “We marry expert consulting with our AI-embedded software that serves as an electronic quality management system (eQMS) and compliance agent. Our software enables clients to manage compliance quickly and easily, even with a small team, and scales as the company grows. It is the only software of its kind, bringing companies into compliance and to market, often six months faster than other solutions.”
FormlyAI supports a wide array of medical technologies, from hardware to AI-driven software, and has already demonstrated significant impact. The platform helps clients save an average of $70,000 in quality and regulatory costs and reduces time-to-market by months. This combination of automation and deep industry expertise sets FormlyAI apart from large consulting firms like RQM+ as well as software vendors Qualio and Greenlight Guru.
Marta Mrozowicz from Heal Capital said: “Medical certification is one of those painful admin processes that companies must go through to place the product in the market. But it doesn’t have to be; that’s why we’ve decided to back FormlyAI, which uses AI to lower barriers to expertise and allows companies to do certification faster and cheaper. We’re excited to be leading this round and back a solution that can enable faster innovation for the entire medtech industry.”
Andrew Brackin of Gradient added: “FormlyAI’s innovative approach to a deeply entrenched industry problem is exactly what we look for. Their ability to combine AI with regulatory expertise to deliver tangible results, like reducing time to market by 10x, showcases their potential to become the industry standard. We are thrilled to support their expansion and continued product development.”
What’s next?
FormlyAI currently serves clients across the US and EU, including established consulting firms. The new funding will accelerate its expansion into additional markets, including Canada and countries participating in the Medical Device Single Audit Program (MDSAP), by year-end. The company will also grow its remote team to support increased operations.
Looking forward, Todd concluded, “We plan to grow our US and EU client base and support additional markets by the end of the year, including Canada and MDSAP countries. As we further develop our software, we will offer additional agentic service offerings to larger, established medical device companies. In a few years, we will manage clients across major markets internationally.”
